Clearance Summary
MULTI CARE THERAPEUTIC VIBRATOR received FDA 510(k) clearance under submission number K010096, sponsored by Multicept A/S. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2001-03-05.
- Submission: K010096
- Applicant / Sponsor: Multicept A/S
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5960
- Decision date: 2001-03-05
Classification & Regulation
This clearance is catalogued under FDA product code KXQ and 21 CFR 884.5960, within the Obstetrics/Gynecology review panel as a Class II device.